Severity
Low
FDA Devices recall · Reported May 27, 2020
Observed an internal repetitive software glitch in ImmersiveView.
Immersivetouch Inc recalled ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-op… - a low-severity action.
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-op… was recalled by Immersivetouch Inc in May 27, 2020. Reason: Observed an internal repetitive software glitch in ImmersiveView.. Check the official notice for the remedy. Verify recall #Z-2041-2020 with the FDA Devices before acting.
The recall
Immersivetouch Inc issued this low-severity FDA Devices recall-Observed an internal repetitive software glitch in ImmersiveView..
Sourced from official FDA Devices enforcement records. Verify recall #Z-2041-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2041-2020) was formally reported on May 27, 2020, with the manufacturer initiating the action on April 3, 2020. It is classified under Low severity (Class III), with a current status of Ongoing. Immersivetouch Inc is listed as the recalling firm, operating out of Chicago, IL. Federal records list the affected scope as 2 units.
The documented reason for this recall is: Observed an internal repetitive software glitch in ImmersiveView. Distribution data in the federal record shows the product reached: The device was distributed in the state of Illinois only.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Low
Affected scope
2 units
Related Recalls
6
3 from same agency
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options
Observed an internal repetitive software glitch in ImmersiveView.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | Z-2041-2020 |
| Date reported | May 27, 2020 |
| Date initiated | April 3, 2020 |
| Recalling firm | Immersivetouch Inc |
| Firm location | Chicago, IL |
| Affected scope | 2 units |
| Distribution | The device was distributed in the state of Illinois only. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 27, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.